Overview

Under the simplified scheme, you must submit data on the quality of the product and show that it is dilute enough to guarantee safety.

The first dilution to be registered must be at least a 1 in 10,000 dilution of the starting material.

The scheme does not allow indications (description of diseases or conditions for which the product is used for).

To qualify for registration under the simplified scheme the products must:

be for oral or external use (excluding injections)

be sufficiently dilute to guarantee safety

make no therapeutic claims

Under the national rules scheme there is no restriction on the first dilution to be authorised or the pharmaceutical form. You can claim that your product is used within the homeopathic tradition for the relief or treatment of minor symptoms and conditions which don’t require the supervision of a doctor.

You must submit data that demonstrates quality, safety and use within the UK homeopathic tradition and you must include details of your labelling and product literature with your application.

How to apply

National applications

If you are not registered with the portal or can’t make your submission electronically you can send MHRA your application on CD or DVD. Please note that MHRA will no longer accept submissions on physical media from 1 February 2016.

Registered or a national rules authorisation products

Fees

Description of homeopathy

Homeopathy is a system of medicine which involves treating the individual with highly diluted substances, given mainly in tablet form. Based on their specific symptoms, a homeopath will match the most appropriate medicine to each patient.

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